B. pertussis is the causative agent of Pertussis, also known as “Whooping Cough.” The CDC reported over 20,000 cases of Pertussis in 2015 in the US 1. Despite the availability of a Pertussis vaccine, immunity is waning, particularly in adolescent and young adult populations. Infants are particularly vulnerable to the disease.
While large molecular respiratory panels are available, the distinctive clinical presentation of B. pertussis demands stand-alone, STAT testing.
Currently, the most common route for Bordetella testing is to send specimens to a state or reference lab which, in the case of a reference lab, can be prohibitively expensive and cause several days – even weeks – delay in obtaining a result, during which time the patient may not be receiving appropriate treatment. Further, specimen collection methods vary by clinical sites, necessitating an assay capable of accepting a broad range of media types.
The Great Basin Bordetella Direct Testis a qualitative in vitro diagnostic test for the detection of Bordetella pertussis DNA from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection attributable to B. pertussis. It identifies the insertion sequence IS481 of Bordetella Pertussis genome.
Negative results for the Great Basin Bordetella Direct Test do not preclude B. pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Great BasinBordetella Direct Test should be used in conjunction with information obtained during the patient's clinical evaluation as an aid in the diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.
This in vitro diagnostic test is configured for use on Great Basin Analyser with Great Basin Bordetella Direct Test Cartridge Kit.
Faster Clinical Decision Making and Improved Patient Outcomes
Increased Lab Productivity
Increasing Laboratory Effectiveness
Attribute | Value |
---|---|
Analytical Sensitivity |
2.4 x 103/span> CFU/mL |
Analytical Reactivity |
Able to detect 100% of all 11 B. pertussis strains |
Analytical Specificity |
No cross-reactivity with 90 other microorganisms tested |
Clinical Sensitivity |
92.5% |
Clinical Specificity |
99.6% |
Reproducibility | 100% |
Sample Type(s) | Nasopharyngeal swabs |
Product | Pack Size | Item Number |
---|---|---|
Great Basin Bordetella Direct Test | 10 | 300782 |
References
CDC: 2015 Final Pertussis Surveillance Report